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| The Verify Evaluation System--Courtesy of Medtronic |
Medtronic ($MDT) is rolling out its upgraded, Bluetooth-enabled wearable device, the Verify Evaluation System. It's for the selection of patients who will benefit from the company's neuromodulation implant to treat chronic overactive bladder or bowel incontinence.
Worn outside the body, the Verify enables patients to temporarily test Medtronic's bladder of bowel control therapy to decide whether they should receive a permanent, subdermal (under the skin) implant called the InterStim System, the company said in release. Medtronic's InterStim System is installed in the upper part of the buttock.
The Minneapolis Star Tribune says the devices are the only ones on the market that provide neurostimulation to the tailbone's sacral nerves, and reports that a 26-year-old patient from Michigan last month became the first person to use the upgraded device.
In June the FDA permitted so-called basic evaluations using the Verify. They last 3-7 days. A Medtronic spokeswoman said the device was previously indicated for advanced evaluations, which may last up to 14 days. In addition, the advanced evaluation requires a minimally invasive procedure to be performed at a hospital, while the basic evaluation can be initiated via an in-office procedure, Medtronic says in a release.
Verify consists of an external neurostimulator, temporary leads and a touch-screen controller. In June, the FDA approved new cable models that enable the basic evaluations.
"Many patients suffering from OAB (overactive bladder) have failed multiple treatments and the Verify System for Basic Evaluations uses new technology to make it easier and faster for patients to assess the potential for effective long-term bladder control," said Dr. Steven Siegel, director, of the Metro Urology Centers for Female Urology and Continence Care in Minneapolis, in a statement. "Trying sacral neuromodulation before committing to the therapy allows patients to make a long-term decision with confidence and with an excellent chance to get their lives back."
According to the Star Tribune, evaluation prior to permanent implantation is needed in part due to the need to configure every InterStim to a particular patient's needs. The Verify and InterStim cost $20,000 to $30,000, and are typically reimbursed by insurance companies. The upgrade increases the cost by about $200.
Medtronic says that more than 37 million Americans have overactive bladder and nearly 18 million suffer from bowel incontinence. Neuromodulation is prescribed if patients are unable to treat the condition using drug and behavioral therapies.
Medtronic is planning the launch of another neurostimulation device for overactive bladder, the Nuro System, which it obtained via the acquisition of Advanced Uro-Solutions in December 2014.
- read the release
- here's more from the Minneapolis Star Tribune